Postoperative AnalgesiaNCT06451354
Postoperative Analgesia After Cesarean Section; Comparison Among Ultrasound Guided Erector Spinae, Quadratus Lumborum or Transversus Abdominis Plane Blocks
A study testing Erector spinae plane block (20 ml bupivacaine 0.25% in each side), Posterior Quadratus lumborum plane block (20 ml bupivacaine 0.25% in each side) and Lateral Transversus abdominis plane block (20 ml bupivacaine 0.25% in each side) in people with Postoperative Analgesia and Cesarean Section, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this prospective randomized controlled study is to compare the analgesic efficacy of the ultrasound-guided erector spinae plane block, ultrasound-guided quadratus lumborum plane block, and ultrasound-guided transversus abdominis plane block in patients undergoing elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Analgesia, Cesarean Section, Erector Spinae Block
- What is being tested?
- Erector spinae plane block (20 ml bupivacaine 0.25% in each side), Posterior Quadratus lumborum plane block (20 ml bupivacaine 0.25% in each side) and Lateral Transversus abdominis plane block (20 ml bupivacaine 0.25% in each side)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- American Society of Anesthesiologists (ASA) classification II.
- Female patients scheduled for elective cesarean section under spinal anesthesia.
Who cannot join
- Patient refusal.
- Patients who are taking analgesics for chronic illness or have history of substance abuse.
- Patients who are unable to describe their postoperative pain (e.g., language barrier or neuropsychiatric disorder).
- Patients with a history of coagulopathy.
- Patients weight less than 60 kilograms.
- Patient height less than 150 cm.
Show all 9Show fewer
- Patients with known local anesthetics and opioid allergy.
- Patients with infection at the site of the needle puncture.
- Patients with major respiratory, cardiac, renal, or hepatic disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia After Cesarean Section; Comparison Among Ultrasound Guided Erector Spinae, Quadratus Lumborum or Transversus Abdominis Plane Blocks: A Prospective Randomized Study
The aim of this prospective randomized controlled study is to compare the analgesic efficacy of the ultrasound-guided erector spinae plane block, ultrasound-guided quadratus lumborum plane block, and ultrasound-guided transversus abdominis plane block in patients undergoing elective cesarean section.
Read the detailed description
Acute postpartum pain is a key determinant of maternal satisfaction; may lead to persistent postoperative pain.
Opioids are used to control severe pain. However, they have many common side effects as sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression.
Transversus abdominis plane (TAP) block is a regional injection of local anesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen. TAP block is an easy technique, and decreases postoperative pain and opioid consumption.
Erector Spinae Plane block (ESPB), first described for analgesia in thoracic neuropathic pain has also been reported for the management of other causes of acute postoperative pain.
Quadratus Lumborum block (QLB) differ from the transversus abdominis plane block (TAP) it is a block of the posterior abdominal wall. It is also referred to as an inter fascial plane block because it requires the injection of a local anesthetic into the thoracolumbar fascia (TLF).
- Conditions
- Postoperative Analgesia, Cesarean Section, Erector Spinae Block, Quadratus Lumborum Block, Transversus Abdominis Plane Block
- Being tested
- Erector spinae plane block (20 ml bupivacaine 0.25% in each side), Posterior Quadratus lumborum plane block (20 ml bupivacaine 0.25% in each side), Lateral Transversus abdominis plane block (20 ml bupivacaine 0.25% in each side)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block (20 ml bupivacaine 0.25% in each side)Other
Patients will receive bilateral ultrasound-guided erector spinae plane block after spinal anesthesia and at the end of surgery. The erector spinae plane block will be performed by using bupivacaine 0.25% (20 ml in each side). Erector spinae plane block will be performed at the level of T9.
Posterior Quadratus lumborum plane block (20 ml bupivacaine 0.25% in each side)Other
Patients will receive bilateral ultrasound-guided quadratus lumborum plane block after spinal anesthesia at the end of surgery. The quadratus lumborum plane block will be performed by using bupivacaine 0.25% (20 ml in each side).
Lateral Transversus abdominis plane block (20 ml bupivacaine 0.25% in each side)Other
Patients will receive bilateral ultrasound-guided transversus abdominis plane block after spinal anesthesia at the end of surgery. The transversus abdominis plane block will be performed by using bupivacaine 0.25% (20 ml in each side) to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients will receive the standard spinal anesthesia with 0.5% hyperbaric bupivacaine (2.2ml) |
| Erector spinae plane block group | Experimental | Patients will receive bilateral ultrasound-guided erector spinae plane block after spinal anesthesia and at the end of surgery. The erector spinae plane block will be performed by using bupivacaine 0.25% (20 ml in each side). Erector spinae plane block will be performed at the level of T9. Receives: Other: Erector spinae plane block (20 ml bupivacaine 0.25% in each side) |
| Posterior Quadratus lumborum plane block group | Experimental | Patients will receive bilateral ultrasound-guided quadratus lumborum plane block after spinal anesthesia at the end of surgery. The quadratus lumborum plane block will be performed by using bupivacaine 0.25% (20 ml in each side). Receives: Other: Posterior Quadratus lumborum plane block (20 ml bupivacaine 0.25% in each side) |
| Lateral Transversus abdominis plane block group | Experimental | Patients will receive bilateral ultrasound-guided transversus abdominis plane block after spinal anesthesia at the end of surgery. The transversus abdominis plane block will be performed by using bupivacaine 0.25% (20 ml in each side) to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest. Receives: Other: Lateral Transversus abdominis plane block (20 ml bupivacaine 0.25% in each side) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption
The rescue analgesia will be morphine IV bolus 3 mg with 5-minute lock out interval when Numeric Rating Scale (NRS)>3, can be repeated till NRS˂3 guided with the occurrence of complication.
Measured: 24 hours postoperatively
Secondary outcomes (4)
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at T1, 2, 4, 6, 12, 18, and 24 h postoperative.
Measured: 24 hours postoperatively
Time for first request of the rescue analgesia
Time for first request of the rescue analgesia will be assessed from the end of surgery to first dose of morphine administrated.
Measured: 24 hours postoperatively
Complications
Complications such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression or any other complication will be recorded.
Measured: 24 hours postoperatively
Degree of patient satisfaction
Degree of patient satisfaction will be assessed using 4-point scale (1, excellent; 2, good; 3, fair; 4, poor).
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Aug 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Gamal Khafagy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451354
- Sponsor's protocol ID
- 35439/4/22
- Status last verified
- Dec 2024
- First submitted
- 2 Jun 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia After Cesarean Section; Comparison Among Ultrasound Guided Erector Spinae, Quadratus Lumborum or Transversus Abdominis Plane Blocks: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06451354
- Acronym / sponsor ID
- 35439/4/22
- Conditions
- Postoperative Analgesia, Cesarean Section, Erector Spinae Block, Quadratus Lumborum Block, Transversus Abdominis Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective randomized controlled study is to compare the analgesic efficacy of the ultrasound-guided erector spinae plane block, ultrasound-guided quadratus lumborum plane block, and ultrasound-guided transversus abdominis plane block in patients undergoing elective cesarean section.
Detailed description
Acute postpartum pain is a key determinant of maternal satisfaction; may lead to persistent postoperative pain.
Opioids are used to control severe pain. However, they have many common side effects as sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression.
Transversus abdominis plane (TAP) block is a regional injection of local anesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen. TAP block is an easy technique, and decreases postoperative pain and opioid consumption.
Erector Spinae Plane block (ESPB), first described for analgesia in thoracic neuropathic pain has also been reported for the management of other causes of acute postoperative pain.
Quadratus Lumborum block (QLB) differ from the transversus abdominis plane block (TAP) it is a block of the posterior abdominal wall. It is also referred to as an inter fascial plane block because it requires the injection of a local anesthetic into the thoracolumbar fascia (TLF).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients will receive the standard spinal anesthesia with 0.5% hyperbaric bupivacaine (2.2ml) |
| Erector spinae plane block group | Experimental | Other: Erector spinae plane block (20 ml bupivacaine 0.25% in each side)Patients will receive bilateral ultrasound-guided erector spinae plane block after spinal anesthesia and at the end of surgery. The erector spinae plane block will be performed by using bupivacaine 0.25% (20 ml in each side). Erector spinae plane block will be performed at the level of T9. |
| Posterior Quadratus lumborum plane block group | Experimental | Other: Posterior Quadratus lumborum plane block (20 ml bupivacaine 0.25% in each side)Patients will receive bilateral ultrasound-guided quadratus lumborum plane block after spinal anesthesia at the end of surgery. The quadratus lumborum plane block will be performed by using bupivacaine 0.25% (20 ml in each side). |
| Lateral Transversus abdominis plane block group | Experimental | Other: Lateral Transversus abdominis plane block (20 ml bupivacaine 0.25% in each side)Patients will receive bilateral ultrasound-guided transversus abdominis plane block after spinal anesthesia at the end of surgery. The transversus abdominis plane block will be performed by using bupivacaine 0.25% (20 ml in each side) to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- American Society of Anesthesiologists (ASA) classification II.
- Female patients scheduled for elective cesarean section under spinal anesthesia.
Key exclusion criteria (9 listed)
- Patient refusal.
- Patients who are taking analgesics for chronic illness or have history of substance abuse.
- Patients who are unable to describe their postoperative pain (e.g., language barrier or neuropsychiatric disorder).
- Patients with a history of coagulopathy.
- Patients weight less than 60 kilograms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spinae plane block (20 ml bupivacaine 0.25% in each side)Patients will receive bilateral ultrasound-guided erector spinae plane block after spinal anesthesia and at the end of surgery. The erector spinae plane block will be performed by using bupivacaine 0.25% (20 ml in each side). Erector spinae plane block will be performed at the level of T9. | Other | Erector spinae plane block group |
| Posterior Quadratus lumborum plane block (20 ml bupivacaine 0.25% in each side)Patients will receive bilateral ultrasound-guided quadratus lumborum plane block after spinal anesthesia at the end of surgery. The quadratus lumborum plane block will be performed by using bupivacaine 0.25% (20 ml in each side). | Other | Posterior Quadratus lumborum plane block group |
| Lateral Transversus abdominis plane block (20 ml bupivacaine 0.25% in each side)Patients will receive bilateral ultrasound-guided transversus abdominis plane block after spinal anesthesia at the end of surgery. The transversus abdominis plane block will be performed by using bupivacaine 0.25% (20 ml in each side) to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest. | Other | Lateral Transversus abdominis plane block group |
Primary outcome
Postoperative morphine consumption
Time frame: 24 hours postoperatively
The rescue analgesia will be morphine IV bolus 3 mg with 5-minute lock out interval when Numeric Rating Scale (NRS)>3, can be repeated till NRS˂3 guided with the occurrence of complication.
4 secondary outcomes
Degree of pain
Time frame: 24 hours postoperatively
Time for first request of the rescue analgesia
Time frame: 24 hours postoperatively
Complications
Time frame: 24 hours postoperatively
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block (20 ml bupivacaine 0.25% in each side), Posterior Quadratus lumborum plane block (20 ml bupivacaine 0.25% in each side) and Lateral Transversus abdominis plane block (20 ml bupivacaine 0.25% in each side) in people with Postoperative Analgesia and Cesarean Section, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morphine consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.